FDA device listing
2.7mm Locking Screw 22mm OS422522,2.7mm Locking Screw 24mm OS422524,2.7mm Locking Screw 8mm OS422508,2.7MM NON LOCKING…
FDA device listing 1748471033 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 2.7mm Locking Screw 22mm OS422522,2.7mm Locking Screw 24mm OS422524,2.7mm Locking Screw 8mm OS422508,2.7MM NON LOCKING SCREW LMM OS422616,3.5mm Locking Screw 22mm (OS421722),3.5mm Locking Screw 24mm (R421724),3.5mm Non-Locking Screw 35mm (OS421835),3.5mm X 20mm Cannulated Screw Self Drill - Tap (OS326920-T),3.5mm X 22mm Cannulated Screw Self Drill - Tap (OS326922-T),3.5mm X 24mm Cannulated Screw… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HRS, HWC, KTT |
| Device names | HRS - Plate, Fixation, Bone, HWC - Screw, Fixation, Bone, KTT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245 |
| FEI numbers | 3025603301, 3033509898, 3036756245 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database